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題名:論申請新藥上市核准的有效性判斷--以美國法制為論述中心
書刊名:成大法學
作者:蘇顯騰
作者(外文):Su, Hsien-teng
出版日期:2019
卷期:37
頁次:頁81-171
主題關鍵詞:新藥上市申請療效有效性藥品有效性之宣稱實質證據隨機化盲性對照組優效性等效性非劣效性統計上顯著性臨床上顯著性New drug applicationNDAEfficacyEffectivenessClaim of drug effectivenessPurport of drug effectivenessSubstantial evidenceRandomizationBlindingControlSuperiorityEquivalenceNon-inferiorityStatistical significanceClinical significance
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期刊論文
1.Schuirmann, D. J.(1987)。A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability。Journal of Pharmacokinetics and Biopharmaceutics,15(6),657-680。  new window
2.Jaeschke, Roman、Singer, Joel、Guyatt, Gordon H.(1989)。Ascertaining the minimal clinically important difference。Controlled Clinical Trials,10(4),407-415。  new window
3.黃欽、趙明(2007)。對臨床試驗統計學假設檢驗中非劣效、等效和優效性設計的認識。中國臨床藥理學雜誌,105,63-67。  延伸查詢new window
4.Atkins, David C.(2005)。Assessing Clinical Significance: Does It Matter Which Method We Use?。Journal of Consulting and Clinical Psychology,73(5)。  new window
5.Berlin, Jesse A.(1989)。An Assessment of Publication Bias Using a Sample of Published Clinical Trials。Journal of the American Statistical Association,84。  new window
6.Cook, Chad E.(20130718)。Clinimetrics Corner: The Minimal Clinically Important Change Score (MCID): A Necessary Pretense。Journal of Manual & Manipulative Therapy,16(4),E82-E83。  new window
7.Darrow, Jonathan J.(2013)。Pharmaceutical Efficacy: The Illusory Legal Standard。Washington and Lee Law Review,70(4)。  new window
8.Dunnett, C. W.、Gent, M.(1977)。Significance testing to establish equivalence between treatments, with special reference to data in the form of 2X2 tables。Biometrics,33(4)。  new window
9.Garrett, A. D.(2003)。Therapeutic Equivalence: Fallacies and Falsification。Statistics in Medicine,22。  new window
10.Greene, Carolyn J.(2008)。Noninferiority and Equivalence Designs: Issues and Implications for Mental Health Research。Journal of Traumatic Stress,21(5)。  new window
11.Hajiro, T.、Nishimura, K.(2002)。Minimal Clinically Significant Difference in Health Status: The Thorny Path of Health Status Measures?。European Respiratory Journal,19(3),390-391。  new window
12.Henderson, Jennifer A.、Smith, John J.(2005)。Realizing the Potential for Biomarkers in Imaging: Background and Legal Basis。Food and Drug Law Journal,60(4),511-524。  new window
13.Katz, Russell(2004)。FDA: Evidentiary Standards for Drug Development and Approval。NeuroRX,1,307-316。  new window
14.Kazdin, Alan E.(1999)。The Meanings and Measurement of Clinical Significance。Journal of Consulting and Clinical Psychology,67(3),332-339。  new window
15.Page, Phil(2014)。Beyond Statistical Significance: Clinical Interpretation of Rehabilitation Research Literature。International Journal of Sports Physical Therapy,9(5),726-736。  new window
16.Walker, Esteban(2011)。Understanding Equivalence and Noninferiority Testing。Journal of General Internal Medicine,26(2),192-196。  new window
17.Peck, Carl C.、Wechsler, Jill(2002)。Report of a Workshop on Confirmatory Evidence to Support a Single Clinical Trial as a Basis for New Drug Approval。Drug Information Journal,36。  new window
18.Sherman, Rachel E.、Anderson, Steven A.、Dal Pan, Gerald J.、Gray, Gerry W.、Gross, Thomas、Hunter, Nina L.、LaVange, Lisa、Marinac-Dabic, Danica、Marks, Peter W.、Robb, Melissa A.、Shuren, Jeffrey、Temple, Robert、Woodcock, Janet、Yue, Lilly Q.、Califf, Robert M.(2016)。Real-World Evidence: What Is It and What Can It Tell Us?。The New England Journal of Medicine,375(23),2293-2297。  new window
19.Skelly, Andrea C.(2011)。Probability, Proof, and Clinical Significance。Evidence-Based Spine-Care Journal,2。  new window
20.Begg, Colin B.、Berlin, Jesse A.(1988)。Publication Bias: A Problem in Interpreting Medical Data。Journal of the Royal Statistical Society, Series A: Statistics in Society,151(3),419-463。  new window
圖書
1.林惠玲、陳正倉(2011)。統計學:方法與應用。雙葉書廊。  延伸查詢new window
 
 
 
 
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